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Our Pipeline

Our portfolio is based on novel scientific targets with the potential for therapeutic application across multiple liver diseases, with a focus on those with high unmet need.

We are leveraging our decades of research and background in bile acids and FXR agonism to expand our pipeline to deliver effective treatments for the growing number of people living with chronic liver diseases.

Primary biliary cholangitis (PBC)

Obeticholic acid±

Phase 4

Preclinical
Phase 1
Phase 2
Phase 3
NDA Filing
FDA/Conditional Approval
Phase 4
Intercept continues to compile data from its Phase 4 study and supplementary real-world evidence from large datasets in the U.S., UK and Europe in support of fulfilling its postmarketing requirements.

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Obeticholic acid + bezafibrate±*

Phase 2

Preclinical
Phase 1
Phase 2
Phase 3
NDA Filing
FDA/Conditional Approval
Phase 4
Intercept is investigating a fixed-dose combination of obeticholic acid (OCA) and bezafibrate for the potential treatment of individuals with PBC. Bezafibrate is a pan-peroxisome proliferatoractivated receptor (pan-PPAR) agonist that is not approved in the U.S. for any indication. Intercept has completed a Phase 1 clinical study in healthy adult subjects that assessed multiple dose combinations of OCA and bezafibrate. The company has two ongoing Phase 2 studies exploring a range of therapeutic doses for the combination of OCA and bezafibrate.

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Severe alcohol-associated hepatitis (sAH)

INT-787, Next-generation FXR agonist*

Phase 2

Preclinical
Phase 1
Phase 2
Phase 3
NDA Filing
FDA/Conditional Approval
Phase 4
INT-787 is Intercept's next-generation farnesoid X receptor (FXR) agonist. Its characteristics provide an opportunity to explore its potential in diseases that involve the gut as well as the liver, such as severe alcohol-associated hepatitis (sAH). INT-787 is currently being evaluated in a Phase 2a proof-of-concept study.

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± Intercept has a license to develop and commercialize in the U.S. only

* Investigational uses have not been approved by the FDA or any other worldwide regulatory agency. Safety and efficacy have not been established.